MicroAire Surgical Instruments, LLC
Charlottesville, VA, US
MICROAIRE SURGICAL INSTRUMENTS LLC appears in FDA device records in Charlottesville, VA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for MicroAire Surgical Instruments, LLC between 1996 and 2025. The busiest year on record is 2022, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2002 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243589 | PAL Sterilization Case | KCT | Substantially Equivalent | |
| K244026 | PAL 7020 Console | QPB | Substantially Equivalent | |
| K242804 | PAL Aspiration System | QPB | Substantially Equivalent | |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | HRX | Substantially Equivalent | |
| K220318 | PAL Infiltration System | QPB | Substantially Equivalent | |
| K212024 | PAL System | QPB | Substantially Equivalent | |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | HRX | Substantially Equivalent | |
| K192694 | PAL Single-Use Cannulas | QPB | Substantially Equivalent | |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | HRX | Substantially Equivalent | |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | QPB | Substantially Equivalent | |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | MUU | Substantially Equivalent | |
| K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC | QPB | Substantially Equivalent | |
| K014060 | MICROAIRE 1000E SYSTEM | HBE | Substantially Equivalent | |
| K981922 | LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI | QPB | Substantially Equivalent | |
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | BTA | Substantially Equivalent | |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | HWE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020601 | 2020601 | MICROAIRE SURGICAL INSTRUMENTS LLC | 3590 Grand Forks Blvd, CHARLOTTESVILLE, VA 22911 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HRXArthroscope
- MOQBattery, Replacement, Rechargeable
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- KDGChisel (Osteotome)
- GDIDissector, Surgical, General & Plastic Surgery
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- EMFKnife, Surgical
- FQHLavage, Jet
- GETMotor, Surgical Instrument, Pneumatic Powered
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- BTAPump, Portable, Aspiration (Manual Or Powered)
- GACRasp, Surgical, General & Plastic Surgery
- CANRegulator, Pressure, Gas Cylinder
- HWCScrew, Fixation, Bone
- FOXStand, Infusion
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GANSuture, Absorbable, Synthetic
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- MUUSystem, Suction, Lipoplasty
- QPBSystem, Suction, Lipoplasty For Removal
- FSMTray, Surgical, Instrument
- BYXTubing, Pressure And Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1975-2025 | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only); | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. | Class II | Open, Classified | |
| Z-2222-2019 | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 | There was a higher than normal incidence rate of the blade not retracting when tightening. | Class II | Terminated | |
| Z-2107-2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum). | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. | Class II | Terminated | |
| Z-0412-2018 | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone | One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) | Class II | Terminated | |
| Z-1407-2017 | MicroAire K-Wires | Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856). | Class II | Terminated | |
| Z-2294-2016 | Endotine Transbleph 3.5 (CFD-080-0167) | MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177). | Class II | Terminated | |
| Z-1834-2016 | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry | MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them. | Class II | Terminated | |
| Z-1328-2016 | MicroAire PAL Cannula Product Usage - Power Aspiration Device | MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice. | Class II | Terminated | |
| Z-1323-2016 | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula | Complaints that the cannula bent/broke during surgery. | Class II | Terminated | |
| Z-2822-2015 | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. | Class II | Terminated | |
| Z-2821-2015 | ASP-1020 LipoTower with Aspiration Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. | Class II | Terminated | |
| Z-2159-2013 | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. | A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility | Class II | Terminated | |
| Z-2158-2013 | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. | A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility | Class II | Terminated | |
| Z-1792-2012 | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures. | Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures. | Class II | Terminated | |
| Z-0044-04 | Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911*** | Wiring pin locking mechanism defective, potential to come apart in surgical site. | Terminated | ||
| Z-0043-04 | Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911***. | Wiring pin locking mechanism defective, potential to come apart in surgical site. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain